CDSCO Enhances Online Portals with Tooltips for Streamlined Application Submissions
These tooltips function as interactive help aids, providing specific instructions and clarifications for each data field. By hovering the cursor over the designated information icon or help text adjacent to a field, users can access concise explanations of the expected input, formatting requirements, and any supporting documentation needed.
CDSCO Introduces Auto-Generated Market Standing and Non-Conviction Certificates for Medical Devices
To facilitate the transition to the new automated system, the CDSCO has announced that all MSC and NCC applications currently in the old workflow will be automatically rejected by the system. The CDSCO has issued a request to all concerned stakeholders to re-submit fresh MSC and NCC applications through the upgraded online system. This ensures that all applications are processed under the new automated workflow.
Government Seeks Input on Revision of Risk Classification of Cardiovascular & Neurological Medical Devices
The government has revisited the existing classification lists for Cardiovascular and Neurological medical devices and added new entries based on their classification as outlined in the First Schedule (Part I) of the MDR, 2017. To ensure a comprehensive and transparent process, the government is seeking input from all concerned associations and stakeholders by May 1, 2025.
Draft In-vitro Diagnostic Medical Device Adverse Event Reporting
The Indian government has released a draft adverse event reporting form for In-vitro Diagnostic Medical Devices (IVD-MDs) for public comments by March 5, 2025.
Correction In Price Issued For Synchrobreathe Inhaler
The price of the Synchrobreathe Inhaler for Budesonide Inhalation (MDI) 200 mcg/dose for 200 doses has therefore been revised to correct a typographical error. It is now fixed at Rs. 81.20 pe.r inhaler
ICMR & CDSCO Seek Input On HMPV Real-Time PCR Evaluation Protocol
The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.
Government Updates Medical Device Classification Lists, Seeks Public Feedback
Drafts of the revised classification lists are available for public review. Stakeholders, including industry associations and medical professionals, are encouraged to provide feedback through the dedicated Google Form by February 5, 2025. Following the feedback period, the CLA will finalize and publish the updated classification lists.
ICMR and CDSCO Seek Public Input on Draft Protocols For Standardizing IVD Testing
ICMR and CDSCO have developed a series of draft standard evaluation protocols for specific IVDs. These protocols outline the methodologies and criteria for testing the quality and performance of these diagnostic tools. ICMR and CDSCO are now inviting comments from all interested stakeholders on these draft protocols. This window for public input closes on February 15, 2025.
Government Seeks Public Input on New Standards for Clinical Electrical Thermometers
The proposed rules mandate verification and stamping of clinical electrical thermometers to ensure compliance with the new standards. These thermometers, used in homes, hospitals, and various industries, play a vital role in diagnosing fevers, hypothermia, and other temperature-related conditions. This additional measure strengthens consumer protection and promotes trust in the devices.
Government Ramps Up Production of Pharmaceuticals and Medical Devices in India
The PLI scheme for Bulk Drugs, with a financial outlay of Rs. 6,940 crore, incentivizes the manufacturing of essential Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). With a budget of Rs. 15,000 crore, the PLI Scheme for Pharmaceuticals focuses on high-value products like patented/off-patented drugs, biopharmaceuticals, complex generics, and anti-cancer drugs. The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices targets high-end medical devices previously imported into India.
